Veru Inc. announced positive topline results from the maintenance extension of its Phase 2b QUALITY clinical trial for enobosarm. The study demonstrated enobosarm’s ability to mitigate weight and fat regain after discontinuing semaglutide, a GLP-1 receptor agonist, while preserving lean mass. Based on the positive results, Veru selected the 3mg dose of enobosarm for its Phase 3 program and has secured a meeting with the FDA.
These findings are particularly relevant for individuals struggling with obesity, especially older adults. Weight regain is a significant challenge after stopping weight loss medications, often accompanied by the loss of lean muscle mass, which can negatively impact metabolism and physical function. Enobosarm’s potential to prevent both weight and fat regain, while preserving lean mass, addresses a critical unmet need in weight management by offering a strategy to sustain weight loss achieved with GLP-1 receptor agonists. This is especially important considering the prevalence of obesity and its associated health risks.
In the 12-week maintenance period after stopping semaglutide, the placebo group regained 43% of their previously lost weight (5.06 lbs). The enobosarm 3mg group regained significantly less weight (2.73 lbs), representing a 46% reduction in weight regain compared to placebo. Importantly, enobosarm completely prevented fat regain in both the 3mg and 6mg dose groups. Over the entire 28-week study period, those receiving enobosarm, followed by enobosarm monotherapy, experienced significantly greater fat loss (58% greater with 3mg and 93% greater with 6mg) and preserved over 100% of their lean mass compared to the placebo group. Furthermore, enobosarm demonstrated a favorable safety profile during the maintenance period, with virtually no gastrointestinal side effects and no adverse events related to liver injury, obstructive sleep apnea, or changes in prostate-specific antigen.
These results position enobosarm as a potential solution for maintaining weight loss after discontinuing semaglutide. A successful Phase 3 program could lead to a new treatment option for individuals managing obesity, potentially improving long-term weight management outcomes and reducing the health risks associated with weight fluctuations and loss of lean mass. This development holds promise for transforming the obesity treatment landscape by offering a sustainable approach to weight control.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
